A Phase 4 interventional study of Invisalign Cleaning Crystals and Fittey Dent Cleaning Tablet in Malocclusion and Cytotoxicity, sponsored by Riyadh Elm University. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by Riyadh Elm University · Phase 4, Interventional, and Prevention
The aim is to evaluate clear aligners' cytotoxicity, leaching, and structural properties and compare them with four cleaning tools. The null hypothesis is the cleansers have no impact on the properties tested.
Orthodontic Invisalign clear aligners patients will be randomly distributed into four groups using four cleaning methods. Participants will be instructed to clean their trays as instructed by the production company.
Leaching, Cytotoxicity, and Structural Confirmation will be evaluated of the Invisalign clear aligners after being used.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 84 is above the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Riyadh Elm University is the lead sponsor of 26 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Invisalign Cleaning Crystals are used as a cleaning method for orthodontic clear aligners. It includes Sodium Sulfate as an active ingredient.
Device: Invisalign Cleaning Crystals
Fittey Dent Cleaning Tablet is used as a cleaning method for orthodontic clear aligners. It includes Sodium Perborate as an active ingredient.
Device: Fittey Dent Cleaning Tablet
Listeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients.
Drug: Listeren Mouthwash
Toothbrush and water is used as a cleaning method for orthodontic clear aligners that as recommended by the aligner manufacturer.
Device: Toothbrush and Water
Invisalign Cleaning Crystals are used as a cleaning method for orthodontic clear aligners. It includes Sodium Sulfate as an active ingredient.
Fittey Dent Cleaning Tablet is used as a cleaning method for orthodontic clear aligners. It includes Sodium Perborate as an active ingredient.
Listeren Mouthwash is used as a cleaning method for orthodontic clear aligners. It includes Eucalyptol and Menthol as active ingredients.
Toothbrush and water is used as a cleaning method for orthodontic clear aligners that as recommended by the aligner manufacturer.
Cytotoxicity
Aligners from each of the four groups will be submerged in normal saline for a month at 37°C to conduct a cytotoxicity assessment. Following that, the solutions were diluted to three distinct concentrations (5%, 10%, and 20% volume/volume). After 48 hours of seeding in 96-well microplates, gingival fibroblasts were exposed to the solution, and the medium will be changed to an MTT solution (MTT: 3-\[4,5-dime-thylthiazol-2-yl\]-2,5-diphenyltetrazolium bromide). Then optical density will be measured to ascertain cell viability and subsequently assess cytotoxicity.
Time frame: 1-2month
Leaching
Each set of aligners from each of the four groups will be cut into 5x5 mm squares. To accelerate the degradation of the sample, each specimen will be submerged in a single glass vial with an alcoholic media. Each material will be soaked in five different solutions as follows: the first is absolute ethanol (100%), the second is 75% ethanol to 25% water, the third is 50% ethanol to water, the fourth is 25% ethanol to 75% water, and finally, 100% water solution served as the control. A gas chromatography-mass spectrometry unit shall be used to analyze the leached substances in the immersion medium. An Agilent GC 7890A combined with a triple-axis detector 5975 C single quadrupole mass spectrometer will be used for GC-MS analysis
Time frame: 1-2months
Structural Conformation
Maxillary and mandibular clear aligners from all four included groups will be cut into 5 × 5 mm squares. Each specimen will be mounted in a plastic mold using an orthodontic plaster to facilitate the indentation process. The microhardness will be tested using a Vickers indenter (INNOVATEST, FALCON 450, Deutschland GmbH) by applying a 25 gf load for 15 s.
Time frame: 1-2months
Plan to share: No
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Riyadh Elm University